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Prometheus redux

The Supreme Court, for a second time, granted a petition for certiorari in Mayo Collaborative Serv. v. Prometheus Labs Inc., No. 10-1150, on June 20, 2011, thereby vacating the Federal Circuit’s December 17, 2010, opinion (628 F.3d 1347) which had been decided on remand for reconsideration in light of Bilski v. Kappos, 130 S. Ct. 3218 (2010). In its December 2011 decision, the Federal Circuit held as patent eligible subject matter under 35 U.S.C. §101 Prometheus’ claims directed to methods of optimizing therapeutic efficacy for a particular disorder. The representative methods include the steps of administering a particular therapeutic compound to a subject having the disorder and determining levels of metabolites of the administered compound in that subject, in addition to the “mental step”, in the form of “wherein” clauses, of comparing the determined levels of metabolites to specific points of reference levels that indicate a need either to increase or decrease the amount of drug administered. See February 14, 2011, IP Insight article by Jeffrey Liao discussing the December decision. The Federal Circuit determined that the administering and determining steps were not just “data gathering”, but were central to the claimed method of optimizing the efficacy of treatment. The current question presented by the Supreme Court is to determine: Whether 35 U.S.C. §101 is satisfied by a patent claim that covers observed correlations between blood test results and patient health, so that the claim effectively preempts all uses of the naturally occuring correlations, simply because wellknown methods used to administer prescription drugs and test blood may involve “transformations” of body chemistry.

The question presented suggests the Supreme Court may consider the claims patent ineligible under §101. The grant of Certiorari describes the case in a similar tone: “This case concerns whether a patentee can monopolize basic, natural biological relationships.” Oral arguments are set for Wednesday, December 7, 2011. Twelve briefs have been filed by amici curiae.